Pronunciation:

en-AL-a-pril MAL-ee-ate, fe-LOE-di-peen

Brand Names:

• Lexxel

Dosage Forms:

• Tablet, Extended Release

Warnings:

ACE inhibitors can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Classifications:

Therapeutic

ACE Inhibitor/Calcium Channel Blocker Combination

Pharmacologic

Enalapril

Chemical

Dihydropyridine

Uses of This Medicine:

Enalapril and felodipine combination belongs to the class of medicines called high blood pressure medicines (antihypertensives). This medicine is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

The exact way in which this medicine works is not known. Enalapril is a type of medicine known as an angiotensin-converting enzyme (ACE) inhibitor. It blocks an enzyme in the body that is necessary in producing a substance that causes blood vessels to tighten. Felodipine is a type of medicine known as a calcium channel blocker. Calcium channel blocking agents affect the movement of calcium into the cells of the heart and blood vessels. The actions of both medicines relax blood vessels, lower blood pressure, and increase the supply of blood and oxygen to the heart.

This medicine was available only with your doctor's prescription.

Enalapril and felodipine combination was discontinued by the manufacturer on July 2, 2008.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of enalapril and felodipine in children with use in other age groups.

Older adults

Although this medicine has not been shown to cause different side effects or problems in older people than it does in younger adults, blood levels of the felodipine component may be increased in the elderly.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Allopurinol
• Amiloride
• Amiodarone
• Atazanavir
• Azathioprine
• Canrenoate
• Cyclosporine
• Dantrolene
• Droperidol
• Eplerenone
• Fentanyl
• Interferon Alfa-2a
• Mibefradil
• Potassium
• Spironolactone
• Triamterene

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Aceclofenac
• Acemetacin
• Alclofenac
• Aliskiren
• Alprenolol
• Amprenavir
• Apazone
• Aspirin
• Atenolol
• Azosemide
• Bemetizide
• Bendroflumethiazide
• Benoxaprofen
• Benzthiazide
• Betaxolol
• Bevantolol
• Bisoprolol
• Bromfenac
• Bucindolol
• Bufexamac
• Bumetanide
• Bupivacaine
• Buthiazide
• Capsaicin
• Carprofen
• Carteolol
• Carvedilol
• Celiprolol
• Chlorothiazide
• Chlorthalidone
• Clometacin
• Clomipramine
• Clonixin
• Clopamide
• Cyclopenthiazide
• Cyclothiazide
• Dalfopristin
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dilevalol
• Dipyrone
• Droxicam
• Esmolol
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Felbinac
• Fenbufen
• Fenoprofen
• Fentiazac
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Furosemide
• Gold Sodium Thiomalate
• Hydrochlorothiazide
• Hydroflumethiazide
• Ibuprofen
• Indapamide
• Indinavir
• Indomethacin
• Indoprofen
• Isoxicam
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Labetalol
• Levobunolol
• Lornoxicam
• Magnesium
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mepindolol
• Metformin
• Methyclothiazide
• Metipranolol
• Metolazone
• Metoprolol
• Nabumetone
• Nadolol
• Naproxen
• Nebivolol
• Nelfinavir
• Nesiritide
• Niflumic Acid
• Nimesulide
• Oxaprozin
• Oxcarbazepine
• Oxprenolol
• Oxyphenbutazone
• Penbutolol
• Phenobarbital
• Phenylbutazone
• Pindolol
• Pirazolac
• Piretanide
• Piroxicam
• Pirprofen
• Polythiazide
• Propranolol
• Propyphenazone
• Proquazone
• Quinethazone
• Quinupristin
• Rifampin
• Rifapentine
• Saquinavir
• Sotalol
• St John's Wort
• Sulindac
• Suprofen
• Talinolol
• Tenidap
• Tenoxicam
• Tertatolol
• Tiaprofenic Acid
• Timolol
• Tolmetin
• Torsemide
• Trichlormethiazide
• Trimethoprim
• Xipamide
• Zomepirac

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angioedema (an allergic skin disease), family history of or unknown cause This medicine should not be used in patients with this condition.

• Bee-sting allergy treatments or
• Dialysis Increased risk of serious allergic reaction occurring.

• Dehydration Lowering effects on blood pressure may be increased.

• Diabetes mellitus (sugar diabetes) Increased risk of potassium levels in the body becoming too high.

• Heart attack or stroke or
• Heart or blood vessel disease or
• Hypotension (low blood pressure) Further lowering of blood pressure may make problems resulting from these conditions worse.

• Kidney disease or
• Liver disease Effects may be increased because of slower removal from the body.

• Previous reaction to any ACE inhibitor involving hoarseness; swelling of the face, mouth, hands, or feet; or sudden trouble in swallowing or breathing Reaction is more likely to occur again.

• Scleroderma or
• Systemic lupus erythematosus (SLE) (or history of) Increased risk of blood problems caused by ACE inhibitors.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor, at the same time each day. Do not take more of it and do not take it more often than directed.

Swallow the tablets whole, without breaking, crushing, or chewing them.

If felodipine is taken with grapefruit juice, its effects may be increased. Check with your doctor before taking this medicine with grapefruit juice.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults 1 tablet once a day to start. Your doctor may increase your dose up to 4 tablets once a day if needed, to equal 20 mg enalapril and 10 mg felodipine extended-release.
    • Children Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly, to check for unwanted effects, and to change the dosage if needed.

If you think that you may have become pregnant, check with your doctor immediately. Use of this medicine, especially during the second and third trimesters (after the first 3 months) of pregnancy, may cause serious injury or even death to the unborn child.

Do not take any other medicines, potassium supplements, or salt substitutes that contain potassium unless approved or prescribed by your doctor.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you experience these effects.

Call your doctor if you faint or feel lightheaded while you are taking this medicine.

Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection developing as a result of low white blood cell counts.

Check with your doctor if you notice difficult breathing or swelling of the face, arms, or legs. These could be symptoms of a serious allergic reaction.

Check with your doctor if you become sick while taking this medicine, especially with severe or continuing vomiting or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Black patients may be less sensitive to the blood pressure-lowering effects of this medicine. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Dizziness, lightheadedness, or fainting

swelling of ankles, feet, or lower legs

Rare

Chills, fever, and sore throat

swelling of face, mouth, hands, or feet

trouble in swallowing or breathing (sudden), accompanied by hoarseness

unusual bleeding or bruising

yellow eyes or skin

Signs and symptoms of too much potassium in the body

Confusion

irregular heartbeat

nervousness

numbness or tingling in the hands, feet, or lips

shortness of breath

weakness or heaviness of legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

Less common

Cough (dry, persistent)

flushing

swelling of the gums

unusual tiredness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.